Clinical trial

Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant

Name

CORT125134-456

Description

This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance and/or uncontrolled systolic hypertension.

Trial arms

Trial start

2020-07-27

Estimated PCD

2024-03-29

Trial end

2024-03-29

Status

Recruiting

Phase

Early phase I

Treatment

relacorilant

Relacorilant is supplied as 100 mg capsules for oral dosing.

Arms:

Relacorilant

Placebo

Placebo is supplied as 100 mg capsules for oral dosing.

Arms:

Placebo

Size

130

Primary endpoint

In patients with diabetes/ impaired glucose tolerance (DM/IGT), the mean change in AUC glucose as compared between relacorilant and placebo arm

Baseline to week 22

In patients with systolic hypertension, the change in mean systolic blood pressure (SBP) based on 24-hour ambulatory blood pressure monitor (ABPM) as compared between relacorilant and placebo arms

Baseline to week 22

Rate of safety based TEAEs

Baseline to week 22

Eligibility criteria

Inclusion Criteria: * Shows lack of cortisol suppression * Suppressed or low early-morning ACTH levels * A radiologically confirmed adrenal lesion * Has IGT or DM * Has uncontrolled hypertension Exclusion Criteria: * Has severe, uncontrolled hypertension * Has poorly controlled DM * Has DM Type 1 * Has significantly abnormal liver test results or severe renal insufficiency * Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}

Updated at

2024-03-07

1 organization

1 product

1 indication

Product

relacorilant

Indication

Cushing's syndrome

Organization

Corcept Therapeutics